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"adult cardiac surgery"

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Introduction to Recombinant Activated Factor VII (rFVIIa) Recombinant activated factor VII (rFVIIa) is approved by the FDA for use in patients with hemophilia A or B with inhibitors, acquired hemophilia, and congenital factor VII deficiency. In the United States, prevalence of hemophilia A and hemophilia B are 1:10,000 and 1:25,000, respectively. Relatively few of these individuals will ever require rFVIIa for treatment as a result of developing antibody inhibitors to the exogenous replacement coagulation factors they are given to replace the deficient factor. In most cases, patients with inhibitors cannot be desensitized to their factor replacement regimen and require rFVIIa to bypass the inhibiting antibodies and to promote clotting during bleeding crises or for surgery and related procedures. The Stanford-UCSF Evidence-based Practice Center used the 2000–2008 data from the Perspective Comparative Database of Premier, Inc. (Charlotte, NC) to assess the in-hospital usage trends of rFVIIa. The Premier database includes information on 40 million annual hospitalizations occurring in 615 U.S. hospitals. Data from the Premier database indicated that in the past decade, off-label use of rFVIIa in the hospital has increased in many other nonhemophiliac bleeding situations that are unresponsive to conventional therapy to control excessive bleeding and reduce exposure to allogeneic blood.
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Introduction to Recombinant Activated Factor VII (rFVIIa)

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | FDA | hemophilia | spontaneous intracranial hemorrhage | trauma | adult cardiac surgery
Clinical Questions Addressed by the Comparative Effectiveness Review The report titled, Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care, addressed the following clinical questions: (1) From an overview of real-world patterns of rFVIIa use and available comparative studies, which clinical populations are receiving off-label rFVIIa and which populations have been scientifically examined, and what are the characteristics of comparative studies evaluating off-label rFVIIa use?; and (2) What are the benefits and harms of using rFVIIa for selected off-label indications in patients with/undergoing: spontaneous intracranial hemorrhage, acquired coagulopathic massive bleeding from body trauma, bleeding from brain trauma, adult cardiac surgery, pediatric cardiac surgery, liver transplantation, or prostatectomy?
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Clinical Questions Addressed by the Comparative Effectiveness Review

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | clinical questions | benefits | harms
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Overview of In-Hospital, Off-Label vs. On-Label rFVIIa Use From the Premier Database (2000–2008)

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | Premier Database | adult cardiac surgery | body trauma | spontaneous intracranial hemorrhage
Mean Differences in Mortality and Thromboembolic Event Rates by Study and rFVIIa Indication This figure includes indications with two or more comparative studies: ICH, body trauma (Trauma), brain trauma (TBI), liver transplantation (LvrTx), and adult cardiac surgery (AdCS). Each circle represents a study; larger circles correspond to larger studies; shaded circles represent studies on treatment use of rFVIIa, and white circles represent studies on prophylactic use of rFVIIa. The mean differences in event rates for the direct (patient-centered) outcomes of total mortality and thromboembolic events are plotted for each comparative study and according to each rFVIIa indication using circle charts, with the area of each circle approximating the total sample size of its respective study. The figures show mean differences in mortality and thromboembolic event rates, respectively, for each comparative study and according to each rFVIIa indication. ICH = intracranial hemorrhage here—although in rest of report “ICH” indicates a subset of intracranial hemorrhage, namely intracerebral hemorrhage; Trauma = body trauma; TBI = brain trauma (traumatic brain injury); LvrTx = liver transplantation; AdCS = adult cardiac surgery
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Mean Differences in Mortality and Thromboembolic Event Rates by Study and rFVIIa Indication

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: mortality | off-label | recombinant factor VIIa | thromboembolic event rates | comparative effectiveness
Evidence of rFVIIa Use for Adult Cardiac Surgery vs. Usual Care Despite advances in methods to control blood loss during and after cardiac surgery, perioperative blood transfusions are required in up to 80 percent of adult patients, and 3 to 5 percent of these patients require postoperative transfusions of over 10 RBC units. Postoperative bleeding that is refractory to surgical re-exploration or conventional hemostatic therapy is felt to be multifactorial, with contributions from the use of antiplatelet agents prior to surgery and various causes of coagulopathy triggered by the surgery itself. There were two RCTs (one good quality, one fair quality) and four comparative observational studies (two good quality, two fair quality) with 251 patients receiving rFVIIa. One of the RCTs assessed prophylactic rFVIIa use, whereas the rest of the studies evaluated treatment use.
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Evidence of rFVIIa Use for Adult Cardiac Surgery vs. Usual Care

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | adult cardiac surgery
Overview of rFVIIa for Adult Cardiac Surgery: Clinical Outcomes The strength of evidence was low for the findings of no effect of rFVIIa use on mortality, units of RBCs transfused, or ICU length of stay. Among the RCTs and higher quality cohort studies, there was a trend toward reduced transfusion requirements with therapy, but no difference in ICU length of stay. Study patients were similar in age to those in the Premier database. Compared to Premier patients, those in the cohort studies had comparable mortality rates, whereas those in the RCTs had somewhat lower mortality rates. The importance and nature of interactions between the timing of treatment use of rFVIIa and important clinical outcomes remain uncertain.
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Overview of rFVIIa for Adult Cardiac Surgery: Clinical Outcomes

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | adult cardiac surgery | outcomes | mortality | red blood cell transfusion | ICU length of stay
Increased Risk of Thromboembolic Events With rFVIIa Use for Adult Cardiac Surgery There is evidence of moderate strength to suggest that the use of rFVIIa in adult cardiac surgery increases the rate of thromboembolic events when compared to usual care. Thus, current evidence of moderate strength (for thromboembolic events) or low strength (for all other outcomes) suggests that neither benefits nor harms substantially exceed each other for rFVIIa use in adult cardiac surgery.
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Increased Risk of Thromboembolic Events With rFVIIa Use for Adult Cardiac Surgery

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | adult cardiac surgery | thromboembolic events
Summary of Outcomes for Most Common Off-Label, In-Hospital Uses of rFVIIa Overall study quality is fair to poor and the strength of evidence is low, with the exception of meta-analyses of intracranial hemorrhage that had moderate strength of evidence for all outcomes and of a meta-analysis of adult cardiac surgery studies that had moderate strength of evidence for the thromboembolic event outcome. Clinical efficacy is often defined via indirect/surrogate outcomes, such as transfusion requirements, change in hematoma volume, or ICU length of stay. Safety is defined via thromboembolic events and mortality, but individual studies often lack the statistical power to assess these outcomes. Evidence of rFVIIa benefit is suggested for several indications, but largely via the surrogate outcomes used in the included studies and with an uncertain relationship to improved patient survival or functional status. In addition, for some uses, rFVIIa produces an increased risk of thromboembolism. Current evidence of low strength suggests the potential for benefits to exceed harms for bleeding from body trauma. There are no indications where potential risks are likely to greatly exceed the benefits. Intracranial hemorrhage: There are four RCTs and one observational study involving 968 rFVIIa-treated patients. Treatment with rFVIIa reduced expansion of intracranial hematoma volume relative to usual care, but increased the risk of arterial thromboembolic events and did not reduce the rates of mortality or poor functional outcome. Current evidence of moderate strength suggests that neither benefits nor harms substantially exceed each other. Adult cardiac surgery: There are two RCTs and four included comparative observational studies with 251 patients receiving prophylactic or therapeutic rFVIIa. These studies showed that rFVIIa likely increased the risk of thrombembolic events, but failed to show an effect of rFVIIa on other outcomes, including mortality. rFVIIa use for this indication is increasing in the U.S. Body trauma: There are two RCTs and two comparative observational studies examining rFVIIa treatment in 257 patients experiencing massive blood loss from trauma. These suggested a possible reduced rate of ARDS, most likely to be present in cases of blunt trauma, but these findings are complicated by the exclusion of patients with early mortality from both of the RCTs and one of the cohort studies. There is no evidence of effect on mortality or of increased thromboembolic events with treatment. Current evidence of low strength suggests the potential for benefit and little evidence of increased harm.
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Summary of Outcomes for Most Common Off-Label, In-Hospital Uses of rFVIIa

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: off-label | recombinant factor VIIa | comparative effectiveness
Conclusions From Available Evidence For the uses examined, current evidence does not show that off-label use of rFVIIa reduces mortality or improves other direct outcomes. Thromboembolic events are increased by using rFVIIa to treat spontaneous intracranial hemorrhage and in adult cardiac surgery.
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Conclusions From Available Evidence

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | conclusions
 
 
 
 
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